System Suitability Testing in the Pharmaceutical Laboratory: Addressing FDA and USP Compliance

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Due to the criticality of the data generated in a pharmaceutical laboratory, System Suitability Testing (SST) has been implemented to provide input on a daily basis about whether or not an analytical method is performing as intended.

This webinar will address the rationale behind System Suitability Testing, how to establish SST as an effective Analytical Control Strategy and what to do if SST does NOT conform to the expectations. We will discuss USP General Chapter <621>, including which analytical parameters may be adjusted to achieve passing SST results.

Objectives of the Presentation

  •  Understand the FDA and USP Requirements for System Suitability Testing
  • Learn which parameters should be included in SST, and how they relate to USP General Chapter <621>
  • Understand how SST, Instrument Qualification and Quality Controls are related, and how they are different
  • Learn what to do if your method fails to meet SST requirements

Areas Covered

  • FDA and USP Requirements for System Suitability Testing (SST)
  • System Suitability Testing as an integral part of Analytical Control Strategy
  • Which Parameters should be included in SST?
  • How does SST relate to USP <621> Chromatography
  • What if you fail the SST criteria?
  • Understanding the relationship among SST, Instrument Qualification and Quality Control Samples
  • Recommendations for non-chromatographic methods
  • Attendee Questions

Target Audience

Chemists (Research, Quality Control, and CRO; Human, Veterinary, Generic or Dietary Supplements) involved with dissolution method development or testing and their managers, QA personnel responsible for reviewing investigations, formulators who rely on dissolution data and regulatory affairs/CMC personnel responsible for filings involving dissolution, Laboratory managers and supervisors , Quality Assurance Managers , GMP auditors ,Consultants.

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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Get in touch

(315) 632-0735,
(315) 750-4379